U.S. patent number 4,798,592 [Application Number 07/107,117] was granted by the patent office on 1989-01-17 for gastrostomy feeding device.
This patent grant is currently assigned to Medical Innovations Corporation. Invention is credited to Stephen K. Parks.
United States Patent |
4,798,592 |
Parks |
* January 17, 1989 |
Gastrostomy feeding device
Abstract
A device is disclosed for supplying food and medication to a
patient, the device being inserted through a stoma and into the
patient's stomach. The device is secured within the stomach by an
inflatable balloon, and on the abdominal wall by an adjustable ring
which also prevents ingestion of the device into the stomach.
During use, the adjustable ring can be retracted to permit cleaning
of the stoma area. The device can be employed with conventional
surgically formed procedures, and is replacable at considerably
longer intervals than present devices. Servicing of the device can
be made at home, rather than at a hospital.
Inventors: |
Parks; Stephen K. (Sunnyvale,
CA) |
Assignee: |
Medical Innovations Corporation
(Milpitas, CA)
|
[*] Notice: |
The portion of the term of this patent
subsequent to October 20, 2004 has been disclaimed. |
Family
ID: |
26804403 |
Appl.
No.: |
07/107,117 |
Filed: |
October 13, 1987 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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670381 |
Nov 5, 1984 |
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Current U.S.
Class: |
604/500;
128/DIG.26; 604/178; 604/533; 604/910 |
Current CPC
Class: |
A61J
15/0015 (20130101); A61J 15/0042 (20130101); A61J
15/0061 (20130101); A61M 25/02 (20130101); A61M
2025/0233 (20130101); Y10S 128/26 (20130101) |
Current International
Class: |
A61J
15/00 (20060101); A61M 25/02 (20060101); A61M
025/02 () |
Field of
Search: |
;604/178,104,96,175,180,280 ;128/DIG.26 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pellegrino; Stephen C.
Attorney, Agent or Firm: Krawitz; Willie
Parent Case Text
This is a continuation, of application Ser. No. 670,381, filed Nov.
5, 1984.
Claims
I claim:
1. A gastrostomy catherter device for feeding into a patient's
stomach, comprising:
a. an elongate feeding tube having a feeding inlet end and a
perforated outlet end for discharging food, the feeding tube
extending outwardly from the patient's stomach to support external
components of the device;
b. an expandable structure mounted on the tube near the outlet
end;
c. means to expand the expandable structure;
d. a closure plug for the feeding inlet and secured to the feeding
tube by an integral band;
e. an adjustable ring slidably mounted along the feeding tube, and
medially thereof, and sized to frictionally engage the tube;
whereby:
i. when the expandable structure is deflated, the feeding tube may
be inserted through a stoma and into the patient's stomach;
ii. when the expandable structure is inflated, it is adapted to
form a seal within the patient's stomach and adjacent the
stoma;
iii. securement of the ring to the tube being provided solely by
frictional engagement therebetween, the ring and tube both being
made of silicone material, to secure the device within the
patient's body and to prevent undesirable movement of the ring
along the tube, whether in the dry state or when lubricated by body
fluids, the locking ring being manually adjustable along the tube
to accommodate to the size of the patient, and the expandable
structure and ring both functioning to maintain the device in place
in the patient;
iv. retraction of the ring along the feeding tube away from the
patient's body being entirely against frictional engagement forces
between the ring and tube to enable the stoma and adjacent areas to
be cleaned; and,
v. when the expandable structure is deflated, retraction of the
feeding tube enables the device to be removed from the patient.
2. The catheter device of claim 1, in which the adjustable ring is
flat.
3. The catheter device of claim 2, in which the adjustable ring is
perforated.
4. The catheter device of claim 1, in which the adjustable ring
provides ridge means on one side thereof, adjacent the patient.
5. The catheter device of claim 4, in which the adjustable ring is
perforated.
6. The catheter device of claim 1, in which the expandable
structure is a balloon mounted around the tube and positioned near
the outlet end of the tube, an inflation valve is mounted near the
inlet end of the tube, and a valve line is connected to the valve
and providing an outlet port within the balloon structure for
inflation thereof, the valve line being positioned adjacent the
feeding tube.
7. The catheter device of claim 1, in which the catheter is sized
12-20 French and having a wall thickness of about 0.035 inches.
8. The catheter device of claim 1, in which the catheter is sized
at least about 12 French.
9. The catheter device of claim 1, in which the catheter is sized
about 12-20 French.
10. A method for gastrostomy feeding, comprising inserting a
gastrostomy tube through a stoma and into a patient's stomach; and,
supplying food through the tube to the patient's stomach, the said
tube comprising:
a. an elongate feeding tube having a feeding inlet end and a
perforated outlet end for discharging food, the feeding tube
extending outwardly from the patient's stomach to support external
components of the device;
b. an expandable structure mounted on the tube near the outlet
end;
c. means to expand the expandable structure;
d. a closure plug for the feeding inlet and secured to the feeding
tube by an integral band;
e. an adjustable ring slidably mounted along the feeding tube, and
medially thereof, and sized to frictionally engage the tube;
whereby:
i. when the expandable structure is deflated, the feeding tube may
be inserted through a stoma and into the patient's stomach;
ii. when the expandable structure is inflated, it is adapted to
form a seal within the patient's stomach and adjacent the
stoma;
iii. securement of the ring to the tube being provided solely by
frictional engagement therebetween, the ring and tube both being
made of silicone material, to secure the device within the
patient's body and to prevent undesirable movement of the ring
along the tube, whether in the dry state or when lubricated by body
fluids, the locking ring being manually adjustable along the tube
to accommodate to the size of the patient, and the expandable
structure and ring both functioning to maintain the device in place
in the patient.
iv. retraction of the feeding tube away from the patient's body
being entirely against frictional engagement forces between the
ring and tube to enable the stoma and adjacent areas to be cleaned;
and,
v. when the expandable structure is deflated, retraction of the
ring along the feeding tube enables the device to be removed from
the patient.
11. The method of claim 10, in which the adjustable ring is
flat.
12. The method of claim 11, in which the adjustable ring is
perforated.
13. The method of claim 10, in which the adjustable ring provides
ridge means on one side thereof, adjacent the patient.
14. The method of claim 13, in which the adjustable ring is
perforated.
15. The method of claim 10, in which the expandable structure is a
balloon mounted around the tube and positioned near the outlet end
of the tube, an inflation valve is mounted near the inlet end of
the tube, and a valve line is connected to the valve and providing
an outlet port within the balloon structure for inflation thereof,
the valve line being positioned adjacent the feeding tube.
16. The method of claim 10, in which the catheter is sized 12-20
French and having a wall thickness of about 0.035".
17. The method of claim 10, in which the closure plug for the
feeding inlet is removed to permit drainage and decompression from
the stomach.
18. The method of claim 10, in which the catheter is sized at least
about 12 French.
19. The method of claim 10, in which the catheter is sized about
12-20 French
Description
BACKGROUND OF THE INVENTION
This invention relates to a new and improved feeding tube, and more
specifically to a gastrostomy feeding tube that is insertable
through a stoma in the patient's stomach wall and secured within
the patient's stomach.
Many types of feeding devices have been developed, but they suffer
from various drawbacks. These include: the ejection or loss of
liquids from the stomach and back out through the device; leaking
around the periphery of the device; and, premature deterioration of
the materials of construction. Also, it is difficult to maintain
the device in place in a stable manner in the patient, and this
latter problem can result in the device being ingested into the
stomach, and eventually into the pylorum. Devices presently on the
market are not sized properly, and they use materials that are
prone to fairly rapid deterioration. Moreover, they can become
entangled and dislodged from the patient due to improper sizing and
inadequate locking of the device to the patient. In some prior art
devices, the exterior of the gastrostomy tube is taped to the
wearer's body, and this can cause infection at the stoma entry, and
along the taped area, as well as causing irritation due to the
difficulty in maintaining these areas clean.
THE INVENTION
According to the invention, a gastrostomy feeding tube is provided
for insertion through the stoma of the patient's stomach wall and
into the patient's stomach. The gastrostomy tube is provided with
an inflatable tube at one end to position and secure the tube
within the stomach. The outer end of the tube is provided with a
moveable locking ring that can be adjusted to accommodate to the
size of the wearer. Since the locking ring does not require or
employ tape to secure the device in place, problems associated with
skin irritation and with maintaining both the taped areas and the
stoma area clean, are greatly reduced. The locking ring can simply
be moved along the tube to permit cleaning of the stoma entry
through which the catheter is inserted. The locking ring is then
repositioned to its normal location, i.e., in close contact with
the wearer's abdomen. The balloon and locking ring thus both
function to maintain the device in place, and prevent the device
from being drawn into the stomach, or inadvertantly pulled out.
The device of this invention is preferably manufactured of a
medical grade silicone elastomer, rather than a latex or silicone
latex combination. Consequently, use of the silicone elastomer
provides a relatively inert material compared to the latex.
Accordingly, the elastomer requires replacement about every 6-8
weeks compared to the silicone latex which needs replacement about
every 3 weeks.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an external perspective view of the gastrostomy device of
this invention;
FIG. 2 is an external perspective view of the said device,
fragmented, showing the outlet end, and the balloon when
deflated;
FIG. 3 is a perspective view, partly broken away, of the said
device installed in a patient; and,
FIG. 4 is an external perspective view of a preferred form of
locking ring employed in the device.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The gastrostomy catheter device 10 of this invention is shown in
FIG. 1, and provides an inlet end 12, through which is fed food and
medication, and an outlet end 13 that extends into the patient's
stomach. A plurality of outlet ports, two of which ports 14, 15 are
shown, and located at the outlet end 13. The catheter 10 is secured
inside the stomach by an inflatable balloon 16, and on the
patient's abdomen by an adjustable silicone locking ring 17. As
shown in FIG. 4, the locking ring 17 is provided with a plurality
of vent holes 17A to permit air to contact the entry to the stoma
and reduce infection and skin irritation. A circular ridge 17B is
formed on the locking ring to improve friction between the ring and
the patient's abdomen.
As indicated, use of the ring prevents the catheter from being
drawn into the patient's stomach. In addition, since the adjustable
ring does not require the use of tape, a potential source of skin
irritation and infection is eliminated. The portion 18 of the
catheter tube 11 between the ring 17 and balloon 16 is secured
within the stoma, and this arrangement of the balloon and ring
prevents the catheter from being drawn into the patient's
stomach.
In FIG. 1, the balloon is inflated by liquid or gas which is passed
through a valve 19 and line 20 into a port 21 that is surrounded by
the balloon. The line 20 is bonded along the inside of the catheter
tube 11 and extends to the outlet of the catheter where it is end
sealed; the end seal forces the inflating gas into the port 21.
FIG. 2 shows the balloon 16 in a deflated position.
The inlet end 12 is provided with an integrally formed end plug 22
attached to the catheter by a band 23. A plurality of rings 24, 25
are formed on the plug to engage corresponding grooves (not shown)
on the inside of the bore at the inlet. The combined effect of the
plug and bore fit, and the fit between the grooves and rings
prevent the plug from being dislodged during use, and hence, will
prevent the contents of the stomach from draining out the
catheter.
Basically, the catheter device is inserted into the patient through
a surgically prepared stoma created in the abdominal wall using
pre-existing surgical procedures. These procedures include Stamms
Gastrostomy, Witzel Gastrostomy, and others. Also, non surgical
procedures may be employed such as percutaneous gastrostomy. The
catheter tube 10, with surrounding, concentric purse string
sutures, is inserted through the stoma and gastric wall into the
stomach. The purse strings will permanently invaginate a portion of
the stomach and stoma to shape around the catheter tube and then
will dissolve, leaving the gastrostomy tube in place and ready for
use. FIG. 3 shows the device when installed. The inflated balloon
forms a gasket that seals the entrance to the stoma, and along with
the locking ring 17, secures the device in place. The device may be
constructed in various sizes to accommodate a particular patient.
Sizes such as 12, 14, 16, 18 and 20 French, and corresponding
diameters varying from about 0.157"-0.263", and a wall thickness of
about 0.035", may be employed.
After being used for a suitable time, say 6-8 weeks, the catheter
tube is, of course, replaced. This is accomplished simply by
deflating the balloon, retracting the adjustable ring, and removing
the tube from the patient.
The present device is inexpensive and can be readily manufactured
by conventional extrusion and injection molding techniques. Also,
it can be easily inserted for use without generally requiring the
services of a physician or even outpatient services.
The device may be cleaned during use and can be manipulated to
permit cleaning of the stoma area. Finally, the device is safe in
that it cannot be drawn into the stomach, which can be particularly
dangerous to unsuspecting infants. During use, it will not
inadvertantly drain the contents of the stomach, because of the end
plug.
* * * * *